GMP Expectations for Products Used in Early Phase IND Studies

GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.


FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

These guidelines remove some of the problems

Audit Trail Generation and Review 2019

How to handle systems without automated audit trails, in a compliant manner.

Audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

How to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.


  • What is an Audit Trail
  • 21 CFR 11 / Annex 11 requirements for Audit Trails
  • Why Audit Trails
  • What are Audit Trail Features
  • What are Audit Trail Contents
  • What records need to have an Audit Trail
  • When does Audit Trail begin
  • What clock should be used for the timestamp
  • How is Audit Trail versioned
  • How is Audit Trail stored
  • What if my system does not have automated Audit Trail
  • What about “hybrid” systems

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.

How to handle systems without automated audit trails


Fast-track review for new (e-cigs) with tech to prevent youth use-[FDA chief]

Agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products.

The Food and Drug Administration is considering fast-tracking the review process for e-cigarettes that include features that make the products less likely to be used by kids, Commissioner Scott Gottlieb told CNBC on Thursday.

Gottlieb last week announced a historic crackdown on e-cigarettes after reviewing unpublished federal data he’s reviewed showing teen use has reached “epidemic” levels. The FDA ordered five brands — Juul, British American Tobacco‘s Vuse, Altria’s MarkTen, Imperial Brands‘ Blu E-cigs and Japan Tobacco’s Logic — to submit plans within 60 days detailing how they will prevent teens from using their products.

Some manufacturers have said the agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products that could curb youth use, including bluetooth features that could disable them near schools.

Yet Gottlieb said while companies have talked about these ideas with reporters and politicians, they haven’t raised them with the FDA. He said the door is “very open to that kind of discussion.”

“I think if someone came to us with a good idea about how a product could be modified to be less appealing to kids or less prone to misuse by children, we’d be very interested in that product, and we’d be very interested in having a discussion around that and how we could put that through an efficient regulatory process,” he said.

Juul, the brand that dominates nearly 73 percent of the e-cigarette market, said it “believes technology is absolutely part of the solution.” The company plans to launch bluetooth-enabled devices internationally next year, according to a person familiar with the matter.

Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022. He said Thursday that the FDA is actively considering reinstating the original deadline, meaning companies may soon be required to submit applications. It may also pull flavored e-cigarette products from the market until those applications are reviewed and cleared.

Critics have scolded Gottlieb for ever giving e-cigarette companies more time. He said it was necessary because it wasn’t clear what the FDA wanted from manufacturers. Now, a year later, the FDA has issued some guidelines and plans to soon release more.

If he had kept the original date, companies would have started sending in applications and wouldn’t have received a decision until next year.

“What we couldn’t anticipate, and what we didn’t anticipate, in all fairness, was how fast the youth use would accelerate,” Gottlieb said.

Finally What Fda cheif says

Do You Hear The Sound Of Internet Of Things [CCP Technologies]

These devices will bridge the gap between the physical and digital worlds, to improve the quality and productivity of life, society and industries.

The Internet of Things (IoT) is no longer the new kid on the block; it is now a staple part of modern society that is rapidly becoming an integral part of modern business.

All-encompassing digital connectivity has the power to transform society, to alter the way people live their lives and how businesses conduct their operations. The IoT has made its case and is now being installed across a raft of businesses globally.

Supply-chain management is one example of an activity that can potentially benefit most greatly from the IoT and its drive to optimise business practices.

For the time being, the IoT has precipitated an avalanche of gadgets and applications, aimed at consumers and the B2C market. Examples include smartphones and watches, security equipment, smart domestic appliances and even driverless cars are all part and parcel of the IoT revolution.

According to market analysts, these devices will bridge the gap between the physical and digital worlds, to improve the quality and productivity of life, society and industries.

A recent survey conducted by KRC Research in the UK, US, Japan and Germany says that some devices are having a more meaningful impact than others — smart appliances like thermostats, refrigerators and home security systems are the first wave of commercial IoT products that customers have been most attracted to.


Parabolic IoT growth

By 2020 the number of IoT connected devices globally is expected to be 30 billion, and this is forecast to grow to 100 billion by 2025.

According to the IoT Alliance in Australia, by 2025 the IoT market could be generating revenue close to US$10 trillion and says that “every person and every business will feel the impact.”

Alternative data obtained by US computer giant Hewlett Packard shows that the number of “connected devices” has risen from 300,000 in 1990 to 90 million by 2008. By 2010, that number reached 5 billion and is on its way to 1 trillion by 2025, according to the company.

The rate of IoT growth globally is becoming parabolic, especially in G20 countries.

With consumers reaping the benefits of connected digital devices, businesses from various industries are keen to participate in this revolution, and by extension, optimise their operations towards delivering services previously thought impossible.

Digitally connected devices are setting the stage for businesses to deliver progressive and scalable services that benefit anyone and everyone.

And it’s not just consumption patterns that are likely to feel the impact of IoT.

The likes of CCP Technologies (ASX: CT1), an ASX-listed IoT-device manufacturer and solutions provider, recently announced that the ‘World Mosquito Program’ at Monash University is using its IoT critical control point monitoring solution to reduce the risk of losing temperature sensitive research material.

“Critical control points” are the points in a supply chain where a failure of standard operating procedure has potential to cause serious harm to people and business continuity, according to CCP.

Standard critical control points include temperature, energy, environment (e.g. air and water quality, pH, chemicals, noise, acoustics and gases) and movement.

If not mitigated, supply chain disruption can directly impact a business’ reputation and its bottom line.

CCP’s solution captures critical control point data in real-time using Smart Tags (sensors) and an advanced IoT platform which leverages big data analytics, machine learning and Blockchain.

What a Huge information from this

Why You Must Keep Carrying Out Risk Management Throughout Your Business [Lifetime]

This places risk management right up there at the very top as among the most crucial elements of a business.

What makes risk management critical? Well, business that comes with no risk is no business at all. It is like the side effect of a medicine. It is impossible to think of the medication without the side effects. Risk being inhered into a business and intricately woven into it; it is necessary to understand why you must keep carrying out risk management throughout your business’ lifetime. This places risk management right up there at the very top as among the most crucial elements of a business.

Management and business experts have propounded the theory that risk can only be managed or contained, and never eliminated. This is the extent to which risk is bound to business. The enormity of risk management can be gauged from the fact that we only hear a term such as risk management, and seldom risk elimination. This indicates the inescapability of risk from a business.


Carrying out risk management throughout the business lifetime is the key

Among the most important aspects to keep in mind about risk management is that it is not something an organization does at some point of time and forgets. It is something that should be carried out every now and then at every point of the business lifetime. Another core point related to this fact is that risks are never single or static. You could face several risks, connected to each other or not, at one point of time.

Further, risks keep changing from time to time. As one risk gets managed, another could spring up. This explains just why as an organization, you must keep carrying out risk management throughout your business’ lifetime. There are very many core reasons for carrying out risk management during the lifetime of the business whenever the occasion demands it.

Understanding the risk is the first step

Risk comes in various forms, shapes and sizes. Anyone who understands a business should start by understanding the risks in it first. Risk could be either relative to the business or the industry or it could be specific to the organization.

Any business is prone to what may be called general risks. Like mentioned, it is a risk that comes with an activity involving a certain kind of business. Irrespective of the nature, size and reach of the business or its market, there are risks such as market, changing consumer tastes, shifting market size and trends, geographical location and so on.

And then, the specific ones

In addition to the general risks that come with any business, a business has to also take into consider the risks that are specific to it, regardless of which industry it is in. Some of the specific risks that come to mind are:

  • Do our employees carry the right skillsets for this industry and this business?
  • Do we have the right resources for growing?
  • How many of our people could be off work on any given day across the business and what are our backup plans?
  • What are our plans for raising funding through the investors and what if they fail to get convinced?
  • What risk will befall our business if the top management quits?
  • What is our disaster recovery plan?
  • Do we have the resilience to handle major disasters and there any that our business is prone to, being located where it is?

Management experts pin down these risk management principles into these main elements:

  • Understanding or establishing the risk
  • Identifying them
  • Analyzing them
  • Evaluating how to manage them.

Do it before it is late

The key to risk management is to not only understand that you must keep carrying out risk management throughout your business’ lifetime, but that you must act before the risk happens. This is where the business’ ken to handling risk management lies. The organization that does this is one that has understood its business best and is ahead of the rest. What happens when risk management is applied after the risk has occurred is that the severity is hardly reduced, while risk management done before the onset of a risk ensures that the risk is contained, and its effects mitigated, which risk management truly is essentially all about.

Models are changing to accommodate growing use of tech [Ogilvy’s] Michael Tidmarsh

It had a lot of promise in the early days, but it seemed to get relegated to banners, and nothing particularly exciting.

In an interview this week, Michael Tidmarsh, chief technical officer for Ogilvy Worldwide, shared his thoughts about how agencies have changed to accommodate data-driven strategies. Tidmarsh will also keynote a talk on creativity in a data-driven world at our MarTech® Conference in Boston in early October.

Tidmarsh said that when he started at Ogilvy in 2003, “… digital was the new, emerging discipline, but it was still a fringe player. It had a lot of promise in the early days, but it seemed to get relegated to banners, and nothing particularly exciting.”

He said that the pace at which digital has moved from the fringe to a mainstream conversation has been surprising.

So you’ve got this landscape where the possibilities of what we can do with tech and data has suddenly shifted. And I think that things like mobile smart phones have paved the way for this, but you’ve suddenly gone from the possibilities of Star Trek-like technology into a world where [that tech is] in your hands every day. [Consumers have] a brand new set of baseline expectations that everything [in tech] is going to be fantastic and more connected than the device that [they] bought before.

In order to keep up the pace, Tidmarsh said, agencies have shifted their models from being traditional AORs (agencies of record) with a substantial retainer to “much more project work, much more bespoke work.”

Asked if the technological concerns in a project ever take over the creative direction, he said that he’s seen tech apply some controls to the creative process:

One example is a piece of work we did a couple of years ago for British Airways, where the creative was an electronic billboard in the center of London that had an animated film of a child on it. When a British Airways plane flew overhead, the child pointed to the sky at the plane and the billboard said something like, “There goes BA 219, just coming home from Spain.”

Everything is going to be changed you know that

Most AI Applications that have real-world business significance for debt collection [today]

Today seem to be in personalizing communications to customers and identifying clusters of similar debtor profiles.

According to the Consumer Financial Protection Bureau, Americans filed more grievances about debt collections than about any other financial incident. Of the 316,810 complaints received by the CFPB about debt collection in 2017, the most common was, “Continued attempts to collect debt not owed,” which was cited by 39 percent of grievance filers.

Debt collection in finance is starting to be disrupted by artificial intelligence due to the availability of massive amounts of historical records of customers for banks and other financial institutions. Most AI applications that have real-world business significance for debt collection today seem to be in personalizing communications to customers and identifying clusters of similar debtor profiles.

From our research we have segmented the AI applications for debt collection into the following broad segments:

  • Driving Additional Messaging Campaigns
  • Customer Service (Debtor) Personalization
  • Debt Management Service

We delve further into each of these applications and aim to coax out the need-to-know factors for business leaders regarding AI usage for debt collection.

Driving Additional Messaging Campaigns

Tailoring interactions to debtor habits could be possible with AI today. Virtual assistants are starting to be deployed through channels in which collections agencies can reach out to debtors through email SMS, and outbound dialing, allowing organizations to increase the number of individuals that they’re able to contact on a daily basis.


TrueAccord was founded in 2013 in San Francisco and claims to be offering an AI-driven debt collection solution. The 97-employee company claims to be offering debt collection solutions to banks, eCommerce and telecom companies.

TrueAccord claims that their decision engine uses machine learning to create digital interaction experiences that are customized for each debtor. The company claims its platform can create an interaction model for each debtor.

TrueAccord claims this model provides banks with the best possible channel and time to reach out to existing and new debtors which might eventually result in better debt revenue collections.

The company says more than 1.5 million debtors have already been modeled using their platform. Based on these existing debtor profiles, their software claims to predict an individual’s response time, schedule, best communication channel, and type of content that they’ll respond to.

TrueAccord adds that its decision engine can automatically select the appropriate pre-approved messages from banks to deliver to debtors. The software also tracks, in real time, the action events from the debtor, such as interaction with call centers, or email opens, link clicks and browsing patterns on TrueAccord assets. The software then sends this data to employees at debt collecting agencies so they can plan the ideal style and time of their next message.

What channel the next message should likely